Effects of Escitalopram on the Sleep EEG Power in Patients With Major Depressive Disorder
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04013464|
Recruitment Status : Completed
First Posted : July 9, 2019
Last Update Posted : July 9, 2019
|Condition or disease||Intervention/treatment||Phase|
|Depressive Disorder, Major||Drug: Escitalopram||Not Applicable|
- Design and participants: The patients with MDD were screened from the hospital, age- and gender-matched healthy controls were recruited by advertising from the community who signed written informed consent before participation.
- Assessments: The 17-item Hamilton Depression Rating Scale (HRSD-17) , Montgomery-Asberg Depression Rating Scale (MADRS), the Clinical Global Impression-Severity scale (CGI-S), and 14-item Hamilton anxiety scale (HAMA) were assessed at baseline and after 8 weeks' treatment with escitalopram for patients with MDD. As for healthy volunteer, these measures were evaluated only once. In addition, all participants were assessed Pittsburgh Sleep Quality Index (PSQI) and Insomnia Severity Index (ISI).
- Treatment: Each patient was provided with escitalopram.
- Collection of peripheral blood samples: Test the levels of plasma melatonin at 4 h intervals for 24 h from all participants.
- Sleep and EEG recordings: The PSG of participants was evaluated for one night at baseline (all participants) and 8 weeks treatment (MDD).
- Analysis the PSG architecture and power ratio.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||31 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Major depressive disorder compared to health control|
|Masking:||None (Open Label)|
|Masking Description:||changed into escitalopram in open treatment and compared to health control|
|Official Title:||Changes of Sleep EEG Power and Melatonin Rhythm in Major Depressive Disoder: a Self-controlled, 8 Weeks Study of Treatment With Escitalopram Compared With Healthy Subjects|
|Actual Study Start Date :||May 1, 2016|
|Actual Primary Completion Date :||May 31, 2018|
|Actual Study Completion Date :||December 30, 2018|
Experimental: MDD and Health Control
MDD in open label
Other Name: no other intervention
- Clinical efficacy of MDD in the treatment of escitalopram [ Time Frame: 8 weeks ]The 17-item Hamilton Depression Rating Scale (HRSD-17) was defined a prior as the primary outcome measure .
- Sleep ratio of EEG power changes in MDD after 8 weeks treatment by escitalopram [ Time Frame: 8 weeks ]polysomnography (PSG) was detected over a night and power analysis was done.
- The levels changes of plasma melatonin after 8 weeks treatment by escitalopram [ Time Frame: 8 weeks ]Test the levels of plasma melatonin at 7 time points during 24 h in MDD.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04013464
|Principal Investigator:||Su-Xia Li, Doctor||National Institute on Drug Dependence, China|